The regulation of cannabis cultivation for medicinal purposes in Brazil remains in evolution and continues to generate legal uncertainty for small rural producers.
Historically, the most common legal pathway to enable individual cultivation has been the safe-conduct order granted through a preventive Habeas Corpus, aimed at preventing potential criminal liability. Case law from the Brazilian Superior Court of Justice (STJ), such as HC 802866 PR, has recognized the right to cultivate for medicinal purposes when therapeutic necessity is demonstrated and specific regulation is absent.
However, authorization is not automatic. The producer must demonstrate strict requirements, including proven medical necessity and technical capacity for cultivation and extraction.
In February 2026, Anvisa issued new Board of Directors Resolutions (RDCs 1.012, 1.013, and 1.014 of 2026), establishing a new regulatory framework for the production, manufacturing, and importation of cannabis-based products. While this represents an important advancement, the regulations primarily target legal entities, research institutions, and patient associations.
The central question remains: how does this framework impact small agricultural producers?
Key regulatory considerations
One of the main aspects concerns THC content control.
- RDC 327/2019 previously set a THC limit of up to 0.2%.
- The new RDC 1.013/2026 addresses medicines containing up to 0.3% THC and requires specific authorization expressly covering cultivation activities.
Despite regulatory progress, there is still no clear framework specifically designed for individual small rural producers. The new rules focus on legal entities subject to prior sanitary inspection or formally organized entities.
This regulatory gap maintains a scenario of legal uncertainty.
Another critical point is the requirement for technical qualification. Even when seeking a judicial safe-conduct order, the producer must demonstrate technical capacity for cultivation, extraction, and quality control.
Finally, ongoing inspection remains a reality. Judicial authorization does not eliminate the obligation to prove that cultivation is strictly for medicinal purposes and that legal thresholds are respected.
Risks and implications
Failure to meet technical and regulatory standards may result in:
- Criminal liability
- Seizure of plants
- Sanitary enforcement actions
The absence of proper administrative authorization may prevent lawful commercialization or regular use of the production.
Regulatory uncertainty may also affect:
- Contractual relationships
- Rural financing
- Insurance coverage
- Commercial partnerships
This is a matter that intersects regulatory, criminal, sanitary, and contractual law.
Strategic recommendations
Small producers should seek preventive legal structuring before initiating any cultivation activities.
Key measures include:
- Obtaining detailed medical reports proving therapeutic necessity
- Demonstrating technical qualification for cultivation and extraction, supported by appropriate professional documentation
- Closely monitoring new resolutions issued by Anvisa and the Ministry of Agriculture, as the regulatory landscape remains dynamic
For companies and associations seeking to establish regular production structures, attention must focus on:
- Obtaining specific sanitary authorization
- Ensuring full compliance with technical and regulatory requirements
Institutional perspective
The regulatory evolution in the medicinal cannabis sector indicates a consolidation process underway. However, areas of uncertainty persist, particularly for individual producers.
Legal maturity and preventive structuring are decisive factors in mitigating risks.
PDK Advogados continuously monitors regulatory and judicial developments involving medicinal cannabis, integrating regulatory, sanitary, criminal, and contractual analysis. We regularly publish insights on regulated sectors, digital law, and corporate governance through our website and institutional channels, connecting law, technology, and market strategy.
